About this trial
This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under fasting and fed conditions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy Thai male and female subjects between the ages of 18 to 55 years.
Body mass index between 18.5 to 30.0 kg/m2.
Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
Non-pregnant woman and not currently breast feeding.
Disqualifiers
History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin.
History of evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, neurologic, allergic disease, or any significant ongoing chronic medical illness.
History of evidence of diabetic ketoacidosis.
History of evidence of genital infections, urinary tract infections within 14 days prior to check-in.
Trial design
Crossover
Treatments tested in this trial
Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
DrugAll participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions.
Treatment groups
Trial outcomes
Primary outcomes
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Primary PK Parameters: Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Primary PK Parameters: Area Under the Curve to Infinity (AUCinf) of Gemigliptin, Dapagliflozin, and Metformin
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Peak Plasma Concentration (Cmax) of Gemigliptin, Dapagliflozin, and Metformin
Secondary outcomes
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Secondary PK Parameters: Time to Maximum(Tmax) Concentration of gemigliptin, dapagliflozin, and metformin
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.
Secondary PK Parameters: Half-life(t1/2) of gemigliptin, dapagliflozin, and metformin
Other outcomes
Assessment - Safety (Adverse events)
A list of all adverse events for each treatment group and for all participants with seriousness, severity, relationship with investigational product. A number of participant with adverse event.
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